As the government considers changes to the law that regulates in-vitro fertilisation, Kurt Sansone draws up a guide to help readers understand the current process and the ethical dilemmas raised by some proposals.

An inter-ministerial committee has been tasked to draft changes but a comprehensive set of proposals was put forward by the Labour Party’s women section.

In a position paper, Nisa Laburisti has asked the government to consider making surrogacy, egg and sperm donation and embryo freezing legal. The three issues raised by Nisa Laburisti are ethically and legally contentious.

But Prime Minister Joseph Muscat has also weighed in on the subject saying he favoured egg and sperm donation and embryo freezing as a means to increase the chances for couples to have children. Dr Muscat is against surrogacy.

The Church and various pro-life organisations have objected to surrogacy and embryo freezing on ethical, legal and moral grounds. Surrogacy has been described as the commodification of the womb while embryo freezing a first step to abortion since it could lead to the death of unborn children.

The National Council of Women has also raised concerns about the fate of unclaimed frozen embryos, saying any changes to the current law risked abandoning the fundamental principle it currently upholds to protect embryos.

Who is eligible for IVF?

The Embryo Protection Act makes it clear that IVF can be provided to heterosexual couples who are either married or in a stable relationship.

How is a stable relationship defined?

The law does not define stable relationship. This is defined by the Embryo Protection Authority.

What does this authority do?

It oversees IVF processes, issues licences to clinics and draws up medical protocols to be followed. It will also ascertain that couples referred to it by doctors are eligible for IVF treatment.

Can gay couples use IVF?

No. The law speaks of heterosexual couples but it also outlaws sperm and egg donation from third parties and surrogate motherhood, all of which are necessary elements in IVF treatment for gay couples. But legal experts have also warned that the IVF law goes against the provisions of the Civil Unions Act that affords the same rights and obligations as marriage to same-sex couples. This is primarily the reason why the Embryo Protection Act has to be changed.

What is surrogate motherhood?

This is when embryos are transferred to a woman other than the one to which the fertilised egg belongs. The woman will carry the pregnancy on behalf of the couple wanting the baby.

What about single people?

They are in the same boat as gay couples. IVF is not possible for single women, who will need somebody to donate sperm, and single men, who will need a surrogate mother.

Is there an exception for sterile couples?

No. In cases when the man or the woman or both do not have gametes, sperm and egg donation are a necessity to undergo IVF. The law makes no exceptions and so sterile couples are not eligible for IVF.

If a couple is eligible, what happens next?

The normal procedures of IVF start with a course of hormone therapy for the woman. The hormones, which are normally taken as pills and injections, stimulate the development of eggs.

Is it a painful process?

It is uncomfortable and can pose the risk of hyperstimulation if one or more eggs grow too much. To avoid this doctors normally ask the woman to have regular ultrasounds towards the end of the cycle to monitor egg growth. This adds to the anxiety.

What happens after?

The woman undergoes a minor operation by which the eggs are harvested from her body and placed in a petri-dish. On the same day, sperm is collected from the partner.

What happens to the eggs?

At this stage doctors try to fertilise the eggs by putting the sperm in the same petri-dish in the hope that fertilisation occurs. If fertilisation does occur, normally some 24 hours later, an embryo is formed. In some cases a sperm is actually injected into the egg to aid the process. This is called ICSI. The embryos are left for three or four days in the petri-dish before being transferred to the woman to determine whether fertilisation had succeeded.

What is an embryo?

An embryo forms when a female egg is fertilised by sperm. The resultant union provides the first human cells with a potential to develop into a baby.

Will all the woman’s eggs be fertilised?

No. The law says doctors cannot intentionally fertilise more than two eggs. This means any extra eggs can be frozen for future use. But specific permission can be given by the authority to implant three fertilised eggs.

Why is there a limit?

Concerns have been raised about multiple pregnancies as a result of IVF processes where more than two embryos are transferred to the woman’s womb. Multiple pregnancies are a risk to the woman and her offspring. The transfer of two embryos seems to be a widely accepted protocol.

Does this mean that all embryos transferred to the woman will result in live births?

No. The pregnancy success rate of IVF using fresh eggs is around 30 per cent. And even if the pregnancy is successful it may still not result in a live birth because miscarriages are also a reality.

Is embryo freezing completely banned?

No. There are exceptions. An embryo can be frozen in grave cases where the doctor has no control over the circumstances after fertilisation has occurred. An embryo is frozen if the woman falls ill, dies, is involved in an accident or simply changes her mind about having a baby before the implantation process occurs.

What happens to the frozen embryos?

If they remain unclaimed by the couple that produced them the authority may give up the embryos for adoption. This means the embryos may be transferred to another woman at some stage. If nobody adopts them they will remain frozen and likely to deteriorate naturally.

Which is the best option: egg or embryo freezing?

It depends who you speak to but there are some basic scientific facts that militate in favour of an IVF programme that uses both options. Bologna doctor and IVF expert Eleonora Porcu uses vitrification, a method that extracts water from the eggs and flash freezes them. She insists this method of storage has given her similar pregnancy results to using fresh eggs or frozen embryos and creates no ethical dilemmas. But according to another Bologna doctor and expert, Luca Gianaroli, running an IVF programme that is based only on egg freezing is expensive and will not be useful for women aged 35 and older. He insists that frozen embryos are more viable than frozen eggs.

Is the IVF process at Mater Dei hospital free?

Not entirely. Although no money is charged for the IVF procedure, couples have to pay for hormone therapy that is a pre-requisite to IVF.

What treatment is offered at Mater Dei?

Women under-40 and who have not conceived after two years of regular unprotected intercourse are able to undergo three IVF interventions while those aged between 40 and 42 are eligible for two cycles.

What legal complications could arise?

The introduction of surrogacy and gamete donation would have to consider the legal standing of the third party donating the gametes or offering her womb to carry the baby.

But the law will also have to take into consideration whether a child will have the right to know who his natural parent or parents are in the case of gamete donation, or whether this will be a completely anonymous process.

As for embryo freezing, which is already possible under force majeure circumstances, the legal dilemma remains the fate of unclaimed embryos and whether these will be allowed to perish naturally or be given up for research apart from adoption.

The obvious risk if freezing becomes an integral part of the IVF programme is the increase in the number of frozen embryos.

Each of these issues carries ethical and moral dilemmas that transcend religious arguments and which will have to be explored in detail.

What are the ethical and moral concerns?

The concerns are many and varied but the principle argument concerning gamete donation and surrogacy surrounds the dignity of the adults involved and the links they will or could develop to the child and the prospective parents.

The objections to embryo freezing primarily stem from the core argument as to whether an embryo has a distinct right to life, over which there are opposing scientific, moral and religious views.

What is the cost of the hormone therapy?

According to the Health Ministry hormone therapy can cost anything up to €2,500 per cycle depending on the medical circumstances of the woman.

In the private sector the IVF procedure, including the drugs, can cost anything between €5,000 and €6,000.

Why have some people described the law restrictive?

The law does not allow more than two fertilised eggs and it outlaws embryo freezing. This can lower the chances for older women or those with particularly serious fertility problems. Scientifically, pregnancy success rates can be improved if all eggs harvested from the woman are fertilised. When this takes place doctors can select the best two embryos to transfer to the womb. The rest can either be discarded or frozen but both options have serious ethical and moral implications.